The introduction of gene therapies and therapeutic proteins has marked a revolutionary step in combating disease. However, these advanced treatments must navigate the challenging landscape of immunogenicity, where the body’s defense system reacts to the introduced medication, potentially negating its therapeutic purpose or worse, reacting against the body’s own proteins. Early in the biologic development process, it’s critical to mitigate such immune reactions to ensure the treatment’s integrity and safety1.
The emergence of anti-drug antibodies (ADAs) in response to biologic medications poses clinical obstacles, from reduced drug effectiveness to serious safety complications. These ADAs have the potential to neutralize drug effects, alter pharmacokinetics (PK), and provoke autoimmune-like responses2. Drug developers are therefore tasked with predicting and curbing the formation of ADAs, crafting therapies that are both efficacious and safe3.
Global regulatory authorities, including the Food and Drug Administration (FDA) and the European Medicines Agency (EMA), mandate a thorough immunogenicity risk assessment before biologics can proceed to clinical trials and market introduction4. This rigorous evaluation process is essential for patient safety, aiding developers to make informed choices that bolster the success and acceptance of new biologic treatments. Comprehensive immunogenicity testing is thus a cornerstone in the journey towards safely integrating pioneering therapies into healthcare.
Abzena’s Immunogenicity Expertise
Abzena has over 20 years of experience in conducting immunogenicity assessments for complex biologics and bioconjugate drug programs. Our unique EpiScreen® platform assesses immunogenicity via flow cytometry and completely avoids radioactive assays, delivering better, more granular candidate selection data. For more information about our Immunogenicity capabilities, click here.
